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PCPSA's 'No Harm' Standard Would Set High Bar For FDA Ingredient Review

 
• By Ryan Nelson

Regulatory consultants have concerns about the draft Personal Care Products Safety Act's proposed standard for FDA ingredient review – reasonable certainty of no harm. The standard's de facto application in FDA's review of new dietary ingredients in the supplement space has resulted in a fail rate of around 75%.

The draft Personal Care Products Safety Act proposes that FDA review cosmetic ingredients against a standard that has proven challenging for the dietary supplement industry and could set unrealistically high consumer expectations, experts suggest.

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More from Legislation

No Longer Voluntary, MoCRA Drives Drastic Increase In Registered Companies, Products

 
• By Lauren Nardella

Preliminary registration data released by FDA offers a first glimpse of the Modernization of Cosmetics Regulation Act’s impact on information the agency has at hand.

WA Regulators Open Rulemaking On Cosmetic Lead Limits; Provide Safe Harbor Under TFCA

 
• By Eileen Francis

The Washington State Department of Ecology publishes ‘Interim Policy on Lead in Cosmetics’ which provides safe harbor options for cosmetic products struggling with the 1ppm limit under the state’s Toxic Free Cosmetics Act, while the department gathers information under a newly opened rulemaking to ‘identify a feasible approach to regulating lead in cosmetic products.’

WA State Regulators Haven’t Softened Stance On Preservatives, Provided Clarity On Penalties As TFCA Effective Date Nears

 
• By Eileen Francis

The Washington Department of Ecology hasn’t backed down on its targeting of formaldehyde-releasing preservatives under the state’s Toxic-Free Cosmetics Act, as industry still awaits a draft final rule. In a recent webinar, attorney Angela Deisch of Amin Wasserman Gurnani, LLP said the department has also not provided clarity on penalties under the law, which goes into effect 1 January.

Industry Support Key To US FDA’s Prospects Under Trump – Califf

 
• By Sue Sutter

The FDA's current leader, whose term will end with Donald Trump’s second inauguration, also described three qualities the agency’s next commissioner will need to succeed, including "believing that there is such a thing as expertise."

More from Policy & Regulation

US FDA Layoffs Expected To Have Ripple Effect On Cosmetics Office Functions

 
• By Lauren Nardella

Functions supporting the US Food and Drug Administration’s Office of Cosmetics and Colors have been impacted by the reduction-in-force.

European Commission’s Omnibus VII Bans Two Nail Care Ingredients Starting In September

 
• By Eileen Francis

Two nail care ingredients included in the European Commission’s Omnibus VII, which includes about two dozen ingredients overall, are banned in Europe in September.

Cosmetics Europe Argues Against Potential Ban Of Common Fragrance, Cosmetic Ingredient Ethanol

 
• By Eileen Francis

Cosmetics Europe is working to obtain derogations for three fragrance and/or cosmetic substances that may be categorized as carcinogenic, mutagenic or reprotoxic, which could result in a ban of their use under the Cosmetic Products Regulation.